Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
9 studies found for:    beriplex p/n
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Rank Status Study
1 Completed Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
Conditions: Coagulation Protein Disorders;   Blood Loss, Surgical;   Perioperative Care
Interventions: Biological: Beriplex® P/N;   Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N;   Other: Fresh Frozen Plasma
2 Completed
Has Results
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
Conditions: Blood Coagulation Disorders;   Acute Major Bleeding
Interventions: Biological: Beriplex® P/N (Kcentra);   Biological: Fresh frozen plasma
3 Completed
Has Results
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
Condition: Reversal of Coagulopathy
Interventions: Biological: Beriplex® P/N (Kcentra);   Biological: Fresh frozen plasma
4 Completed A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation
Condition: Bleeding
Interventions: Drug: 60mg edoxaban;   Drug: 180mg edoxaban;   Drug: 50 IU/kg Beriplex P/N;   Drug: 25 IU/kg Beriplex P/N;   Drug: 10 IU/kg Beriplex P/N
5 Completed A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers
Condition: Healthy
Interventions: Drug: Rivaroxaban 20 mg twice daily;   Drug: Rivaroxaban 20 mg once daily;   Drug: Profilnine SD;   Drug: Beriplex P/N;   Other: Saline
6 Completed A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects
Condition: Anticoagulation
Interventions: Drug: Apixaban;   Drug: Cofact (4-Factor PCC);   Drug: Beriplex P/N (4-Factor PCC);   Drug: Placebo (Saline solution)
7 Completed Prothrombin Complex Concentrate for Anticoagulant Reversal
Condition: Acquired Coagulation Factor Deficiency
Intervention: Drug: Prothrombin Complex Concentrate
8 Recruiting Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects
Conditions: Acute Major Bleeding;   Reversal of Coagulopathy
Intervention: Biological: BE1116 (Prothrombin Complex Concentrate)
9 Completed Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass
Condition: Cardiopulmonary Bypass
Interventions: Drug: Recombinant activated factor VII;   Drug: Prothrombin Complex Concentrate

Indicates status has not been verified in more than two years